Browse Drug Recalls

1,110 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,110 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 1,110 FDA drug recalls in CA.

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DateProductReasonClassFirm
Aug 7, 2026 Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 5140... CGMP deviations: tablets with black specks. Class II Golden State Medical Supply Inc.
Jul 15, 2026 Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dos... Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan Class III Asclemed USA Inc.
Jun 8, 2026 Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only,... Lack of Assurance of Sterility Class II Asclemed USA Inc.
Jun 8, 2026 Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL sin... Lack of Assurance of Sterility Class II Asclemed USA Inc.
Jun 4, 2026 Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed b... CGMP Deviations Class II Amgen, Inc.
Jun 4, 2026 Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed b... CGMP Deviations Class II Amgen, Inc.
Jun 4, 2026 Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed b... CGMP Deviations Class II Amgen, Inc.
Jun 4, 2026 Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 5... Presence of Foreign Substance. Class II Amgen, Inc.
Jun 4, 2026 Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., ... Presence of Foreign Substance. Class II Amgen, Inc.
Jun 1, 2026 BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Pr... Microbial Contamination of Non-Sterile Products Class I BEEKEEPER'S NATURALS USA INC.
May 29, 2026 GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets... Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was o... Class II Golden State Medical Supply Inc.
May 14, 2026 Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem ... CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox... Class II Asclemed USA Inc.
Apr 27, 2026 Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: L... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Golden State Medical Supply Inc.
Apr 27, 2026 Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lan... Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. Class III Golden State Medical Supply Inc.
Apr 27, 2026 Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle... Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution foll... Class II Oasis Medical, Inc.
Apr 8, 2026 TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Ma... CGMP Deviations; the firm discontinued required stability testing for products on the market stil... Class II Blaine Labs Inc
Apr 8, 2026 TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 ... CGMP Deviations: product manufactured in the same facility under the same conditions as the produ... Class II Blaine Labs Inc
Apr 8, 2026 vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manuf... CGMP Deviations; the firm discontinued required stability testing for products on the market stil... Class II Blaine Labs Inc
Apr 8, 2026 Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) ... CGMP Deviations; product manufactured in the same facility under the same conditions as the produ... Class II Blaine Labs Inc
Apr 8, 2026 TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL)... CGMP Deviations; the firm discontinued required stability testing for products on the market stil... Class II Blaine Labs Inc
Apr 8, 2026 Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ ... Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus... Class I Blaine Labs Inc
Apr 8, 2026 Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains,... CGMP Deviations; the firm discontinued required stability testing for products on the market stil... Class II Blaine Labs Inc
Apr 8, 2026 TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 F... CGMP Deviations; the firm discontinued required stability testing for products on the market stil... Class II Blaine Labs Inc
Apr 1, 2026 EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MED... Lack of Assurance of Sterility Class II International Medication Systems Ltd.
Mar 25, 2026 Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polye... Lack of Assurance of Sterility Class II Preferred Pharmaceuticals, Inc.
Mar 3, 2026 STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene ... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and t... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene ... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (1... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), S... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidon... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Dec 27, 2025 TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per b... Incorrect Product Formulation: product did not contain insulin as listed in the label. Class II Central Admixture Pharmacy Services, Inc (CAPS)...
Nov 26, 2025 Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, ... Presence of Foreign Tablets/Capsules Class II Golden State Medical Supply Inc.
Nov 17, 2025 Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Phar... Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, ... Class II Preferred Pharmaceuticals, Inc.
Oct 20, 2025 SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Wo... Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam. Class I ANTHONY TRINH, 123Herbals LLC
Oct 20, 2025 NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx onl... Failed Dissolution Specifications Class II Golden State Medical Supply Inc.
Oct 10, 2025 Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottl... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, ... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) p... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Ar... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Dis... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g pe... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% an... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 ... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per... CGMP Deviations Class II CA BOTANA International, Inc.
Oct 10, 2025 Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 O... CGMP Deviations Class II CA BOTANA International, Inc.

Frequently Asked Questions

When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.